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Preface


Drug abuse continues to be a significant problem in the United States. Preventing the diversion of legitimate drugs into the illicit market and the abuse of prescription medication, particularly controlled substances, is of great importance to DEA.

There are more than 1,000 NTPs registered with DEA, including methadone maintenance programs, methadone detoxification services, and compounders. The vast majority of these programs voluntarily comply with the Controlled Substances Act of 1970 (CSA) and its implementing regulations. The importance of proper control of the use of all approved narcotic replacement pharmacotherapies by NTP sponsors and staff cannot be overemphasized.

DEA policy and regulations require that all NTPs provide a complete and accurate accounting of all controlled substance medications received and dispensed. Factors that may affect a program's ability to maintain accurate inventory control and correct dispensing procedures include manufacturing standards for bottle fill, use of automatic dispensing pump equipment, effective integration of computer software programs, proper training of dispensing personnel, and accurate recordkeeping in the reconciliation of daily narcotic inventories. The purpose of these guidelines is to help NTPs interpret regulatory requirements and strengthen their ability to maintain accurate dispensing records in compliance with federal law.

It should be noted that some states have more stringent and/or additional requirements than those mandated by federal law. NTPs must comply with these more stringent and/or additional requirements. While the following guidelines include DEA regulatory requirements, NTPs should also consult with their State Methadone Authority, or its equivalent, to ensure compliance with state regulatory statutes.

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